Events

Recall of IH CONTROL 2

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by EFS Alpes Méditerranée.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2003-12-03
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-du-dmdiv-ih-control-2-de-l-efs-alpes-mediterranee-marseille
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    The EFS Alpes Méditerranée - site of Marseille withdraws from the market the batch 03122310101 (per.23.12.03) of the in vitro diagnostic medical device called IH CONTROL 2 - reference IHC02, following a nonconformity of the red blood cell A2 consisting of the presence of the antigen c (RH4) while this is not expected. This device corresponds to a panel of red blood cells and serum (or plasma) intended for internal quality control of ABO-RH1 groupings, RH-KEL phenotypes and the search for anti-erythrocyte antibodies.

Device

IH CONTROL 2

Manufacturer

EFS Alpes Méditerranée
  • Source
    LAANSM